Surgical Anchoring Device, Deployment Device, and Method of Use

ABSTRACT

A surgical anchoring device may include a first beam and a second beam each extending along a longitudinal direction; and a connecting member bridging a first proximal portion of the first beam to a second proximal portion of the second beam such that the first beam is substantially aligned with the second beam. In addition, the anchoring device may include a first barb protruding from a medial side of the first beam, wherein the first barb extends diagonally in a generally proximal direction; and a second barb protruding from a medial side of the second beam, wherein the second barb extends diagonally in a generally proximal direction. The first barb may include a proximal facing surface that is separated from the first beam by a recess.

CROSS-SECTION TO RELATED APPLICATIONS

This application is a divisional of Running et al., U.S. PatentApplication Publ. No. 2021/0275161, published Sep. 9, 2021, and entitled“Surgical Anchoring Device, Deployment Device, and Method of Use,” whichclaims the benefit of U.S. Provisional Patent Application No.62/972,718, filed on Feb. 11, 2020, and titled “Anchoring Device forTissue and Method of Insertion,” and U.S. Provisional Patent ApplicationNo. 62/972,722, filed on Feb. 11, 2020, and titled “Deployment Devicefor Inserting Anchors into Tissue.” The entire disclosure of eachapplication listed above is incorporated herein by reference.

BACKGROUND

The present embodiments relate generally to medical devices, and inparticular to medical devices used to repair tissue.

Rotator cuff repair is a surgical procedure performed to repair torn (orpartially torn) tendons in the shoulder. This procedure can be done withlarge incisions or with arthroscopic techniques. To repair a torn tendon(such as the supraspinatus tendon), a surgeon may use anchors andsutures to reattach the tendon to the humerus bone. The repaired areamay then be covered with a graft to facilitate healing.

Currently, grafts may be applied using anchors to fix the graft to theunderlying tendon and/or bone. The anchors may cause inflammation.Additionally, the anchors are implanted by inserting a device throughone or more openings at the top of the shoulder, which can make itdifficult to access all of the desired joint spaces.

There is a need in the art for a system and method that addresses theshortcomings discussed above.

SUMMARY

In one aspect, the present disclosure is directed to a surgicalanchoring device. The anchoring device may include a first beam and asecond beam each extending along a longitudinal direction and aconnecting member bridging a first proximal portion of the first beam toa second proximal portion of the second beam such that the first beam issubstantially aligned with the second beam. In addition, the anchoringdevice may include a first barb protruding from a medial side of thefirst beam, wherein the first barb extends diagonally in a generallyproximal direction. The first barb may include a proximal facing surfacethat is separated from the first beam by a recess.

In another aspect, the present disclosure is directed to a surgicalanchoring device. The anchoring device may include a first beam and asecond beam bridged by a connecting member. The anchoring device mayfurther include a first set of barbs protruding from the first beam, thefirst set of barbs including a first barb and a second barb; and asecond set of barbs protruding from the second beam, the second set ofbarbs including a third barb and a fourth barb. At least one of thebarbs may include a tip portion corresponding to an intersection of aproximal surface, a first side surface, a second side surface, and adistal ridge surface.

In another aspect, the present disclosure is directed to method ofimplanting a surgical anchoring device. The method may include providinga deployment device loaded with a first anchoring device comprising aframe structure including a first beam and a second beam bridgedtogether by a connecting member and having a retention portion proximatea distal end of the first anchoring device configured to resistwithdrawal of the anchoring device from tissue. The deployment devicemay further include at least one pair of needle members, including afirst needle member and a second needle member configured to receive thefirst beam and the second beam of the first anchoring device, at leastone anchor engaging rod configured to engage with the first anchoringdevice when disposed within the needle members; and at least one pushingmember configured engage the pair of needle members and the anchorengaging rod. The method may include actuating the at least one pushingmember, thereby translating the pair of needles and the first anchoringdevice from a first position within the deployment device to a secondposition extending from the distal end of the deployment device. Themethod may also include retracting the needle members independent of theanchor engaging rod such that the anchor engaging rod maintains theanchoring device in the second position, thereby releasing the anchoringdevice from the needle members.

Other systems, methods, features, and advantages of the embodiments willbe, or will become, apparent to one of ordinary skill in the art uponexamination of the following figures and detailed description. It isintended that all such additional systems, methods, features, andadvantages be included within this description and this summary, bewithin the scope of the embodiments, and be protected by the followingclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments can be better understood with reference to the followingdrawings and description. The components in the figures are notnecessarily to scale, emphasis instead being placed upon illustratingthe principles of the embodiments. Moreover, in the figures, likereference numerals designate corresponding parts throughout thedifferent views.

FIG. 1 is a schematic view of a step in a procedure for repairing arotator cuff tendon, according to an embodiment;

FIG. 2 is a schematic view of a step of applying a graft to a portion ofa rotator cuff tendon to facilitate healing, according to an embodiment;

FIG. 3 is a schematic view of an embodiment of an anchoring device;

FIG. 4A is a schematic top-down view of an embodiment of an anchoringdevice;

FIG. 4B is a schematic bottom-side view of an embodiment of an anchoringdevice;

FIG. 4C is a schematic side view of an embodiment of an anchoringdevice;

FIG. 5 is a schematic perspective side view of an anchoring device,according to an embodiment;

FIG. 6 is a schematic perspective top view of an anchoring device,according to an embodiment;

FIG. 7 is a schematic view of a portion of an anchoring device,according to another embodiment;

FIG. 8 is a schematic perspective side view of an anchoring device,according to an embodiment;

FIG. 9 is a schematic side view of a deployment device, according to anembodiment;

FIG. 10 is a schematic perspective rear view of a deployment device,according to an embodiment;

FIG. 11 is a schematic bottom view of a deployment device, according toan embodiment;

FIG. 12 is a schematic illustration of a deployment device, according toan embodiment viewed from a distal end of the device;

FIG. 13A is a schematic cutaway perspective view of a portion of adeployment device, according to an embodiment;

FIG. 13B is a schematic exploded view of the body portion of thedeployment device of FIG. 13A, according to an embodiment;

FIG. 14A is a schematic perspective view of a deployment tube assembly,according to an embodiment;

FIG. 14B is a schematic cutaway perspective view of a portion of adeployment device, according to an embodiment;

FIG. 15 is a schematic exploded view of the tube assembly of thedeployment device of FIGS. 14A and 14B, according to an embodiment;

FIG. 16 is a schematic exploded view of a distal portion of the tubeassembly of the deployment device of FIGS. 14A and 14B, according to anembodiment;

FIGS. 17A-19 present schematic views of a deployment device in a lockedconfiguration with a pair of anchoring devices loaded onto thedeployment device, according to an embodiment;

FIGS. 20-23 present schematic views of the deployment device in anactuated configuration, according to an embodiment;

FIGS. 24-26 present schematic views of the deployment device in adeployed configuration whereby a first anchoring device is deployed,according to an embodiment;

FIGS. 27-29 present schematic views of the deployment device in a lockedconfiguration with a single anchoring device loaded onto the deploymentdevice, according to an embodiment;

FIGS. 30 and 31 present schematic views of the deployment device in anactuated configuration, according to an embodiment;

FIGS. 32 and 33 present schematic views of the deployment device in adeployed configuration whereby a second anchoring device is deployed,according to an embodiment; and

FIGS. 34 and 35 are schematic, perspective illustrations of needlemembers with an anchoring device disposed therein in a configuration inwhich the two elements are driven into tissue/graft material.

DETAILED DESCRIPTION

The embodiments provide an anchoring system that can be used to secure agraft in place over underlying tissue (such as tendons and/or bones)within the body. For example, the anchoring system can be used to securethe graft over a rotator cuff tendon and/or part of the humerus bone.The anchoring system includes an anchoring device and a deploymentdevice (or instrument) that is used to insert portions of the anchoringdevice through a graft and underlying tissue.

The anchoring device of the embodiments comprises an arch-shaped body orframe structure that includes a plurality of barbs. The frame structureincludes a first beam and a second beam. The proximal end portions ofthe two beams are bridged by a connecting member. Barbs protrude from aninterior-facing or medial side of each beam. Each barb is orienteddiagonally inward and proximally upward in a direction toward a centrallongitudinal axis. As the anchoring device is inserted into tissue, theorientation of the barbs ensures that the anchoring device resists anyforces that would act to pull out the anchoring device from the tissue.

The deployment device of the embodiments comprises a body that can begripped in one hand by a user and an elongated deployment tube assemblythat extends from the body to a tip. The deployment tube assemblyincludes a pair of tubes in which the anchoring device may be movablysecured or retained. An internal pushing member can be deployed using atrigger on the body. When the anchoring device is loaded in thedeployment device and the deployment device is triggered, the pushingmember can move an anchor engaging rod and needle members to extend bothfrom the distal tip of the deployment device, thus driving the needlemembers through the graft and underlying tissue with the anchoringdevice disposed within the needle members. Then, the needle members areretracted, leaving the anchoring device behind in the graft/tissue.

Because the anchoring device is loaded along the exterior of thedeployment device, the diameter of the deployment tube assembly can bekept sufficiently small and may be inserted through or directed towardvery small arthroscopic incisions. The design of the deployment devicefacilitates a lateral approach to the shoulder. This enables access tothe joint space under the acrom ion, which can be more difficult toaccess when approached head-on from the top aspect of the shoulder.

FIG. 1 is a schematic view illustrating a surgical procedure to repair atendon in a patient's shoulder. Specifically, a patient 100 isundergoing arthroscopic surgery that is performed by surgeon 102. Alsoshown in FIG. 1 is an enlarged view of a portion of humerus 110 androtator cuff tendons 112. In the present example, surgeon 102 hasrecently applied anchors and sutures to secure supraspinatus tendon 114to humerus 110.

Once the tendon has been sufficiently repaired, surgeon 102 may insert agraft through an incision (possibly using another device to facilitateinsertion). The graft can then be placed over the repaired tendon and/orportion of the underlying bone in order to facilitate healing. As anexample, FIG. 2 shows a schematic view of a graft 202 that has beenapplied over the recently repaired tendon 114 as well as over a portionof humerus 110.

Although the exemplary embodiment depicts a procedure in which a tendonis first secured to the bone using sutures and anchors, in otherembodiments a graft can be applied to one or more tendons without firstreattaching a tendon. For example, grafts could be applied to tendonsthat have only partial tears. Further, it will be understood that thedisclosed anchoring device may be utilized to secure materials otherthan grafts. For example, the anchoring device may be used to securesoft tissue to other soft tissue or to secure soft tissue to bone. Also,in some embodiments, the anchors may be used to secure sheet-likeimplants (other than grafts), as well as provide anchor points forsutures.

Once graft 202 has been placed over the repaired tendon, one or moresutures or anchors are required to hold graft 202 in place. The presentembodiments disclose both a filament with anchoring elements that can beused to hold a graft in place, as well as an instrument for deployingthe filament with anchoring elements.

FIG. 3 is a schematic view of an anchoring device 300 that may be usedto secure a graft in place along a tendon, bone, and/or at the interfaceof a tendon and bone. Anchoring device 300 may comprise a framestructure 350 that includes a first beam 310 and a second beam 320bridged by a connecting member 330. In addition, the anchoring device300 includes a plurality of barbs (“barbs”) 360 extending or protrudingoutward from the first beam 310 and the second beam 320. Specifically,the first beam 310 includes a first barb 362 and a second barb 366, andthe second beam 320 includes a third barb 364 and a fourth barb 368.Portions or areas of the first beam 310 and/or second beam 320 thatinclude barbs will be referred to as barbed regions, and portions orareas of the first beam 310 and/or second beam 320 without barbs will bereferred to as unbarbed regions.

In some embodiments, exterior surfaces in the unbarbed regions aregenerally smooth. Moreover, unlike the barbs, whose cross-sectional sizevaries along their length due to the tapering shape of each barb, theunbarbed beam portions may have an approximately constantcross-sectional size corresponding to the diameter of the beam and/orconnecting member. In FIG. 3 , the first beam 310 and second beam 320are substantially cylindrical in shape, such that the body of each beamwill have a circular cross-section. However, in other embodiments, thebeam structure may encompass any elongated geometry, including rods andbars of different curvatures and shapes. Similarly, the connectingmember 330 may also have a substantially circular cross-sectional shape,but in other embodiments may have another shape. In differentembodiments, the components/elements may include any three-dimensionalshape. For example, in FIG. 3 , while the beams are substantially linearor straight, the connecting member 330 is curved in an arc-shape. Inaddition, it may be appreciated that in different embodiments, barbscould have any suitable geometry. Exemplary geometries include, but arenot limited to: T-bar geometries, arrowhead geometries, wedgegeometries, pyramidal geometries, etc. It may be appreciated thatembodiments could employ any suitable barb-like elements or elementsthat resist pull-out from a material along a particular direction.

In some cases, anchoring device 300 could comprise a monolithicstructure, with both the frame structure and barbs constructed of asingle unitary piece of material. For example, anchoring device 300could be a 3D printed structure formed from a single biocompatiblematerial. In other cases, the frame structure and barbs could comprisedistinct structures mechanically joined. In one example, an anchoringdevice could be made by coating a beam comprised of a firstbiocompatible material with a second biocompatible material. At somelocations along the beam, the second biocompatible material coatingcould be shaped into barbs. In another example, each set of barbs couldbe formed as a sleeve of material that can be placed over a beam andfixed in place, for example, using an adhesive. In this case, the beamand the sleeve could be made of different materials. Furthermore,depending on the desired applications, the anchoring device 300 could behollow or solid, and/or portions of the anchoring device 300 may befilled or hollow. For example, in cases where a different distributionof weight would benefit the patient, the anchoring device 300 could beprinted with some portions being hollow and lighter, and other portionsbeing filled and heavier. When bioabsorbable materials are utilized, itmay be advantageous to vary the overall thickness of different portionsof the anchoring device as a way to control the amount of time it takeseach portion to dissolve in the body.

The number of barbs associated with an anchoring device, as well astheir distribution along the beams, could vary. In some cases, the barbscould be arranged in approximately regular patterns. For example, in theembodiment shown in FIG. 3 , the anchoring device 300 comprises fourbarbs, symmetrically located on the opposing beams. In otherembodiments, the anchoring device could comprise any suitable differentnumbers of barbs, spaced at any suitable intervals. The number of barbscould be selected according to the intended depth of penetration of ananchor as well as the desired resistance to any pull-out forces thatwould act to tug the anchor out of the tissue after it has beeninstalled. In different embodiments, the length of the unbarbed portionsmay be selected so that they are long enough to allow movement of theanchoring device, but not too long to make implantation difficult.Further, the length of the unbarbed portions may be long enough to passthrough the thickness of a graft so that the barbs engage the tissuebeneath the graft. Accordingly, it may be appreciated that an anchoringdevice may be manufactured with any suitable length and include anynumber of barbs.

For clarity, the description makes reference to distal and proximaldirections (or portions). As used herein, the distal direction is adirection oriented away from a user who is holding a device. Also, theproximal direction is a direction oriented toward a user who is holdinga device. Thus, a distal side or region refers to a portion of thedevice that is disposed further from the user holding the device and aproximal side or region refers to a portion of a device that is disposednearer to the user holding the device during normal use.

In addition, the terms medial and lateral refer to sides of a device orcomponent/element thereof, where a medial side of a component generallyfaces toward a center of the device, and a lateral side of a componentgenerally faces away from the center of the device.

Furthermore, the term “longitudinal axis” as used throughout thisdetailed description and in the claims refers to an axis that extends ina longitudinal direction, which is a direction extending the length ofeach device, including the anchoring device and the deployment device.In the present case, a longitudinal axis extends in the proximal-distaldirection.

The term “lateral axis” as used throughout this detailed description andin the claims refers to an axis that extends in a lateral direction,which is a direction running a width of each device, including theanchoring device and the deployment device. In addition, the term“transverse axis” as used throughout this detailed description and inthe claims refers to an axis that extends in a transverse direction,which is a direction running along a thickness of each device, includingthe anchoring device and the deployment device. Each axis of the threeaxes may be understood to be orthogonal relative to the other two axes.

In FIG. 3 , for purposes of reference, a longitudinal axis 390, lateralaxis 370, and transverse axis 380 are indicated. In addition, theanchoring device 300 is shown to include a distal end 374 and a proximalend 372. A medial side 394 is also labeled for purposes of example onthe side of the first beam 310 closer to a central longitudinal axis 396(shown in dotted line) that generally divides the anchoring device 300in two equal parts. The side that faces outward or away from the centeris labeled as a lateral side 398. In addition, a proximal end 372 of theanchoring device 300 is the end that is above or toward the top of thedrawing (e.g., the end including the connecting member 330), while adistal end 374 of the anchoring device 300 is the end that is below ortoward the bottom in the drawing (e.g., the end including the barbs360). For purposes of convenience, terms such as below, bottom, lower,etc. may also be used to describe the distal end or distal portions ofthe anchoring device, while terms such as above, top, higher, etc. mayalso be used to describe proximal end or proximal portions of theanchoring device.

For purposes of reference, a central lateral axis 398 (shown in dottedline) is included that generally demarcates the lateral midline of theanchoring device 300 into a proximal region 342 and a distal region 344.In addition, while anchoring device 300 is substantially symmetrical ormirror-images with respect to the central longitudinal axis 396,anchoring device 300 is asymmetrical with respect to the central lateralaxis 398.

In some embodiments, anchoring device 300 can have a shape thatresembles an archway. For example, as shown in FIG. 3 , the connectingmember 330 can represent the top of the arch, and the first beam 310 andsecond beam 320 can correspond to the pillars supporting the arch.Furthermore, in some embodiments, the lengths of the beams 310 and 320can be greater than the length of the connecting member 330 (extendingfrom a first end 338 to a second end 336). In some cases, a beam canhave a length that is 1.5-2 times greater than the length of theconnecting member 330. In one embodiment, a straight-line distancebetween first end 338 and second end 336 can correspond to half thelength of a beam.

In the embodiment of FIG. 3 , the distal side of the connecting memberand the medial sides of the two beams are joined to form a substantiallysmooth, continuous curvature. In some other examples, the anchoringdevice 300 may be understood to have a substantially U-shaped structure(in FIG. 3 , the “U” shape is upside-down). Thus, in one embodiment, theouter components or elements (i.e., the first beam 310, second beam 320,and connecting member 330) can provide a boundary or perimeter thatsurrounds an interior area 340. In FIG. 3 , the interior area 340 has asubstantially parabolic shape or outline. It is within this interiorarea 340 that the barbs 360 are disposed.

In different embodiments, the barbs 360 may be arranged in variouspositions along a medial surface of one or both of the beams. In theembodiment presented herein, a first spacing between the first barb 362and second barb 366 is substantially similar to a second spacing betweenthe third barb 364 and fourth barb 368. However, in other embodiments,the spacing between different barbed areas can alternate between arelatively longer spacing and a relatively shorter spacing (e.g., suchthat the anchoring device 300 is no longer symmetrical with respect tothe central longitudinal axis 396). More specifically, in FIG. 3 , thespace between the barbs on each beam is selected to ensure that thebarbs 360 are disposed in the distal region 344 of the anchoring device300, while the proximal region 342 remains unbarbed, optimizing theresistance to pull-out forces that might tug on the anchoring device 300after it has been implanted in tissue. For example, the barbs 360 willbe inserted first (being located in the distal portion of the device)when the anchoring device 300 is pushed into tissue, while the proximalportion remains unbarbed to facilitate the ability of the deploymentdevice to grip and move the anchoring device 300, and then to extendthrough a graft and ultimately provide stability to the anchoring device300 once it has been installed. In other cases, however, the arrangementof barbs could occur in any other suitable pattern that supports theintended depth of penetration as well as the desired resistance to anypull-out forces.

In some embodiments, the orientation of the barbs 360 serve to ensurethat the anchoring device 300 resists any forces that would act to pullout the anchoring device from the tissue. The orientation depicted inFIG. 3 has been shown to provide an increased resistance to pull-out. InFIG. 3 , each barb of the anchoring device 300 is oriented diagonallyupward in a generally proximal direction. Specifically, the first barb362 is oriented along a first direction D1, the second barb 366 isoriented along a second direction D2, the third barb 364 is orientedalong a third direction D3, and the fourth barb 368 is oriented along afourth direction D4, where each direction D1-D4 corresponds to theaverage or general direction of the protruding barb (e.g., the proximaland distal surfaces of each barb extend in directions that are eitherless steep or steeper than the central direction labeled as D1-D4). Inthe embodiment of FIG. 3 , the first direction D1 corresponds to thefirst barb 362 extending in a direction toward the intersection betweenthe connecting member 330 and second beam 320 (around second end 336 ofconnecting member 330), while the third direction D3 is roughlyopposite, corresponding to the third barb 364 extending in a directiontoward the intersection between the connecting member 330 and first beam320 (around first end 338 of connecting member 330). Furthermore, thesecond direction D2 corresponds to the second barb 366 extending in adirection toward the distal surface (lower side) of the third barb 364,and then toward the portion of second beam 320 near the central lateralaxis 398, while the fourth direction D4 corresponds to the fourth barb368 extending in a direction toward the distal surface (lower side) ofthe first barb 362, and then toward the portion of first beam 310 nearthe central lateral axis 398. Thus, the orientation of the barbs 360forms a double crisscross shape.

In different embodiments, an anchoring device could be configured tohave a variety of sizes for the frame structure and barbs. In somecases, the frame structure could have a diameter in-between 0.5 mm and 2mm. In other cases, the frame structure could have a diameter of lessthan 0.5 mm. In still other cases, the frame structure could have adiameter of greater than 2 mm. Also, each barb could have a maximumradial length of between 1 mm and 5 mm. In other cases, each barb couldhave a maximum radial length that is greater than 5 mm.

An anchoring device may be made of a variety of materials. In somecases, an anchoring device could be made of one or more biocompatiblematerials. A biocompatible material may be any natural or syntheticmaterial that can be used to replace tissue or to function while beingin contact with other tissue in a manner that does not damage theadjacent tissue. Examples of biocompatible materials include, but arenot limited to: metals, ceramics, and polymers. More specific examplesinclude nylon, prolene, dacron, polydioxanone (PDS), polypropylene andultra high molecular weight polyethylene (UHMWPE). In some cases, thebiocompatible material could be a bioabsorbable polymer that isgradually absorbed by adjacent tissue. Examples of bioabsorbablematerials include poly L-lactic acid (PLLA), polyglycolic acid (PGA),polytetrafluorethylene (PTFE), polyaryletherketone (PAEK),polyetheretherketone (PEEK), and poly-(D, Lactic acid) (PDLLA).

For purposes of clarity, additional views of the anchoring device 300are now provided in FIGS. 4A-4C. FIG. 4A depicts the anchoring device300 in a top-down view, in which the viewer looks directly at proximalend 372. In some embodiments, first beam 310 and second beam 320, whilesubstantially smooth and have a constant cross-sectional size along asubstantial majority of their exterior surface, can also includeadditional elements. For example, first beam 310 includes a firstenlarged crown element (“first crown”) 410, and second beam 320 includesa second enlarged crown element (“second crown”) 420. In addition, afirst width W1 (in this case also corresponding to a diameter of firstcrown 410) is also substantially equal to a second width W2(corresponding to a diameter of second crown 420), while a third widthW3 of the connecting member 330 is smaller than either first width W1 orsecond width W2, where each width is measured along the transverse axis380.

The crown elements of the anchoring device may have the same diameter asthe inner diameter of the needle members (1512A, 1512B, 1522A, and1522B) discussed below with respect to FIGS. 16, 34, and 35 , amongother figures. This maintains stability of the anchoring device whilethe needle members are being retracted with respect to the anchordevice. It will be understood that, although the crown elements areshown at the proximal ends of the beams, these enlarged needle engagingelements may be disposed at any location along the length of the beams.

In some embodiments, the shape of the distal tips of the anchoringdevice may have substantially the same shape as the distal tips of theneedle members. For example, in order to correspond with a Greene tipneedle, the bevels at the distal tips of the anchoring devices mayinclude a scalloped portion 397 along the side of the beams, as shown inFIG. 3 . This scalloped portion corresponds to a curved aspect of aGreene tip needle grind. The geometry at the distal tips of theanchoring devices helps prevent the anchors from going into compressionduring insertion through tissue/graft material. This feature isdiscussed in greater detail with respect to FIGS. 34 and 35 below.

In some embodiments, the beams may terminate in surfaces that havedifferent shapes at the proximal end than at the distal end of thebeams. For example, in some embodiments, the beams may have a proximalend that terminates in a substantially circular surface, and a distalend that terminates in a substantially teardrop-shaped surface. Forexample, both the first crown 410 and second crown 420 each have aproximal-side facing surface that is substantially circular(corresponding to the base ends of the cylindrical beams) and labeledhere as a first disc 412 and a second disc 422. The exterior surfaces offirst disc 412 and second disc 422 are substantially flat and planar andsmooth. As will be discussed in later figures, the shape and dimensionsof the discs are selected to align with and rest flush against thepushing portions of the deployment device. In addition, in someembodiments, the surface of first disc 412 and second disc 422 isoriented in a substantially orthogonal direction relative to theorientation of the cylindrical portion of the beams.

FIG. 4B depicts the anchoring device 300 in an upside-down view, inwhich the viewer looks directly at distal end 374. In this view, adistal or first bottom surface 414 of second barb 364 and a secondbottom surface 424 of fourth barb 368 can be more clearly seen, as wellas the distal surface of connecting member 330. In some embodiments, afourth width W4 is also substantially equal to the first width W1 (seeFIG. 4A), and a fifth width W5 is substantially equal to the secondwidth W2 (see FIG. 4A), which allows for the smooth translation of theanchoring device 300 along the deployment tubes of deployment device, aswill be discussed below. FIG. 4B also depicts the tapered geometry ofthe bottom surfaces of the barbs having a teardrop-shape. Furthermore,as will be more clearly shown in later figures, the first bottom surface414 and second bottom surface 424 are substantially flat or planar, andare oriented in a diagonally upward direction such that a tapered tip474 is further proximal and medial relative to a rounded outer edgeportion 472 of each surface. That is, first bottom surface 414 andsecond bottom surface 424 are oriented at an oblique angle relative tothe lateral axis 370 (see also FIG. 3 ).

FIG. 4C presents a lateral side view of anchoring device 300. In FIG.4C, the structure of crown elements can be seen more clearly. In FIG.4C, first crown 410 is shown, comprising a cylindrical portion with aslightly greater diameter than that of the beam body below. In addition,in some embodiments, the first crown 410 includes an upper crown portion416 and a lower crown portion 418 that is narrower than the upper crownportion 416. The lower crown portion 418 can smooth the transitionbetween the beam body and the upper crown portion 416. For example, insome embodiments, lower crown portion 418 may be a beveled surface, asshown in FIG. 4C. Thus, overall, the crown elements may be enlarged withrespect to the beams. In addition, the lateral side view illustrates theadditional length of anchoring device 300 provided by the curvature ofconnecting member 330. It can be seen that a top-most portion ofconnecting member 330 (corresponding to its center) extends furtherproximally relative to the proximal end of first beam 310.

For purposes of reference, each beam can be understood to comprise threeregions. As an example, in FIG. 5 , the second beam 320 is shown asincluding a proximal region 550, an intermediate region 552, and adistal region 554. Descriptions of second beam 320 should be understoodto apply to the first beam 310 (and vice-versa). The intermediate region552 extends between the proximal region 550 and distal region 554 andcomprises an unbarbed and substantially smooth portion of the beam. Incontrast, the proximal region 552 is joined on its medial side to thesecond end 336 of the connecting member 330, and includes second crown420, while distal region 554 is barbed with third barb 364 and fourthbarb 368.

In addition, each barb can be understood to include a base portion 510and a tapered portion 520, where the two portions are joined to form acontinuous element. The base portion 510 protrudes outward from themedial side of the first beam 310 and provides structural support andreinforcement to the tapered portion 520 of the barb. In addition, thebase portion 510 has a smaller first lateral length 512 than a secondlateral length 522 of the tapered portion 520.

Additional details regarding the barbs are now provided with referenceto FIGS. 6-9 . FIG. 6 depicts a perspective top view of the anchoringdevice 300, in which a top surface 610 of the third barb 364 isdiscussed as an example. Details for the top surface 610 may beunderstood to be applicable to other barbs. In this view, the shape oftop surface 610 can be more clearly seen, comprising a substantiallyarrowhead-like shape, extending from a first side 630 with a first width632, decreasing to a second width 634 in a central region 620, andtapering or diminishing to a narrow point or rounded tip portion 640with a width of close to zero. Furthermore, top surface 610 issubstantially smooth and flat, and extends in a diagonally upwarddirection as it approaches the tip 640.

FIG. 7 presents a magnified view of the distal region 554 of second beam320, including third barb 364 and fourth barb 368. Because the anchoringdevice 300 is substantially symmetrical it should be understood thatdetails provided for third barb 364 may also be applicable to the firstbarb and details for fourth barb 368 may also be applicable to thesecond barb. In FIG. 7 , a first tapered portion 792 of third barb 364can be seen to include multiple surface sides, including a proximalfacing top surface 610, a first lower surface 720, a first side surface722, and a ridge surface 718. In some embodiments, the tapered portioncan include a roughly semi-pyramidal three-dimensional shape. Inaddition, because anchoring device 300 is symmetrical across lateralaxis 370 in the direction of transverse axis 380, it can be understoodthat the tapered portion 792 also includes a second lower surface and asecond side surface on the opposite side. Each of the four surfacescomprising ridge surface (“ridge”) 718, top surface 610, first lowersurface 720, and second lower surface (not shown) merge into tip portion640, which can have a narrow, rounded tip or a more pointed or sharptip. In addition, first lower surface 720 can be seen to extendpartially underneath a first base portion 794 of third barb 364. Firstbase portion 794 protrudes outward from a base 732 that is joined to thesecond beam 320, and includes an arm portion 796 that extends distallydownward toward fourth barb 368 until tapering to a point. First baseportion 794 also includes a first upper surface defining a recess 750.That is, the proximal facing upper surface 610 may be separated frombeam 320 by recess 750. Recess 750 provides barb 364 with a hookedshape, which prevents pull out from tissue. It also provides a narrowerbase profile, which facilitates penetration into tissue. In addition, inorder to provide this narrower base profile with reinforcement, areinforcing rib 746 may be disposed within recess 750. The reinforcementrib 746 protrudes upward from recess 750 and extends into the body ofthe first tapered portion 792 that adds greater structural support tothe barb.

A spacing 754 between the two barbs can be more clearly seen in FIG. 7 ,extending from the end of the arm portion 796 of the third barb 364 to asecond upper surface 710 of the fourth barb 368. While the two barbs canbe understood to be very similar, one structural feature of fourth barb368 that differs from third barb 364 is the shape of the lower surface.While third barb 364 had a first lower surface 720 that continued untilreaching arm portion 796, a lowermost surface 780 of the fourth barb 368can be seen to extend further as a smooth and continuous plane from atip 786 to an outer edge portion 788, abutting the teardrop-shapedsecond bottom surface 424 (see FIG. 4B), along a bottom-most end 770 ofsecond beam 320.

Further structural details of barbs can be seen in the upside-down viewof FIG. 8 . In FIG. 8 , the surfaces of first barb 362 and second barb366 are presented, more clearly illustrating the ridges of each. Secondbarb 366 includes first bottom surface 414 extending diagonally in aproximal direction from a bottommost end 890 of first beam 310 untilreaching a first ridge 718. First ridge 718 is a substantiallyrectangular panel that runs along the bottom of the tapered portion ofthe second barb 366 and extends in a more sharply upward direction thanfirst bottom surface 414. The first ridge 718 corresponds to a centralregion of the barb where a first lower surface 880 and a second lowersurface 882 come together. The first lower surface 880, second lowersurface 882, first ridge 718, and top surface (not shown) merge into atip 884. In contrast, a second ridge 816 of first barb 362 extendsfurther along the distal surface of the barb, until forking into twoprongs 818 toward opposing sides of the first beam 310, thereby forminga Y-shape.

The anchoring device of the embodiments can be implanted using anassembly that extends needle pairs and anchoring devices from a distaltip of the deployment device. The needles pierce into the tissue of thepatient. Then, the needles are retracted, while a pushing membermaintains the position of the anchoring device relative to thedeployment device, thus leaving the anchoring device in the graft and/ortissue. In some embodiments, the general method for implanting ananchoring device described above can be accomplished using a deploymentdevice such as that described below. Specifically, the deployment devicemay include both a pushing member, as well as components that canactuate the pushing member to simultaneously drive the needle pairs andanchoring device through a graft and into underlying tissue. Thedeployment device can then release the anchoring device into the graftand/or tissue by retracting the needles.

FIG. 9 is a schematic exterior side view of an example of a deploymentdevice 900. Additional schematic views of deployment device 900 areshown in FIGS. 10-12 . Deployment device 900 can be used to deploy ananchoring device comprised of two beams with barbed portions andunbarbed portions (for example, anchoring device 300 of FIG. 3 ). Inparticular, deployment device 900 can be used to deploy the anchoringdevice discussed earlier into tissue.

As shown in FIG. 9 , deployment device 900 is comprised of a bodyportion (“body”) 920 that is coupled to a deployment tube assembly(“tube assembly”) 910. In this exterior view, the body 920 can be seento include an external housing 926 extending longitudinally between aforward end 952 and a rear end 950, as well as a handgrip trigger 922, aplurality of fasteners 928, and an optional first selector button 924that is currently in an unpressed, neutral, initial, protruding, ordefault state. The fasteners 928 in this case are secured withinrecesses formed in the housing 926. In addition, in some embodiments,the handgrip trigger 922 can have a forward portion that protrudesoutward before curving up toward the housing 926 and then extendingdownward to provide a larger second portion, thereby providing contoursthat form a user-friendly gripping unit. For purposes of convenience,terms such as forward, front, etc. may also be used to describe featuresdisposed toward a distal end of the deployment device, while terms suchas rearward, rear, back, etc. may also be used to describe featuresdisposed toward a proximal end of the deployment device. In the exteriorviews of FIGS. 9-12 , the deployment tube assembly 910 can be seen tocomprise a tube housing 914 that is connected to a tip portion 912. Amaximum first transverse width 942 of the tube assembly 910 issignificantly smaller than a maximum second transverse width 944 of thebody 920. Deployment tube assembly 910 may include provisions forinserting an anchoring device through a graft and/or tissue, and will bediscussed further with reference to FIGS. 14A-16 .

For purposes of reference, in FIG. 9 and other figures, the deploymentdevice 900 is presented with directional labels, including a distal end930 (toward the tip portion 912), a proximal end 934 (toward the rearend 950), a lower side 932, and an upper side 936. In FIGS. 10-12 , afirst side 1030 and a second side 1032 (relative to a central lateralaxis 1270) are also identified. In some embodiments, first side 1030 andsecond side 1032 represent two complementary, and in some cases,substantially symmetrical or mirror-image portions of deployment device900 relative to central lateral axis 1270.

In FIG. 11 , a bottom-side-up perspective view of deployment device 900is shown. It can be seen that tube housing 914 is substantiallycylindrical (i.e., with a substantially circular cross-sectional shapein a lateral plane), where a first lateral width 1142 is equal orapproximately the same as the first transverse width 942 in FIG. 9 . Inother embodiments, the tube housing 914 may have an oval or oblongcross-sectional shape. In addition, the body 920 has a second lateralwidth 1148 that is smaller than the second transverse width 944 of FIG.9 . Furthermore, in some embodiments, a first longitudinal length 1144of the tube assembly 910 is similar to a second longitudinal length 1146of the body 920, though in other embodiments, the dimensions of eachcomponent may differ based, for example, on the dimensions of theanchoring device being implanted. For example, in some embodiments, thetube assembly may be much longer than the body portion in order toprovide greater flexibility of movement to an operator. FIG. 11 alsomore clearly depicts the selector mechanism, including the two selectorbuttons, namely first selector button 924 and second selector button1124 disposed on the opposite side. Second selector button 1124 is, forpurposes of illustration, in the depressed state in FIG. 11 , and has anouter surface that is nearly flush with the outer surface of the housing926.

In addition, in some embodiments, the handgrip trigger 922 may include atexturing or other surface patterns that can improve the security of auser's grip on the device. For example, as shown in FIG. 11 , handgriptrigger 922 may include nubs or bumps to improve grip.

In the forward-facing view of FIG. 12 (facing toward distal side 930)additional details of the tube assembly 910 can be seen. The tubeassembly 910 extends from the body 920 in the region surrounding atransverse midline 1270 (extending from upper side 936 to lower side932) that demarcates the region in which a first housing side 1242 joinsto a second housing side 1244. While in some embodiments the deploymentdevice 900 may be configured to deliver one anchoring device beforerequiring a ‘reload’, in some embodiments, the deployment device 900 caninclude a dual deployment system whereby two anchoring devices may bestored at the same time, allowing for delivery of two differentanchoring devices in short order. Such a configuration is shown in FIG.12 , where a primary opening 1230 of the tip portion 912, correspondingto a distal end of the deployment device 900, offers a view of theinterior of the tube assembly 910. The tip portion 912 substantiallysurrounds a first anchoring device (“first anchor”) 1210 disposed aboveand a second anchoring device (“second anchor”) 1220 disposed below.

In different embodiments, the first anchor 1210 and second anchor 1210may correspond to the anchoring device 300 described above. In someembodiments, the two anchors may be arranged within deployment device900 such that they are substantially symmetrical relative to alongitudinal axis extending through a central point 1250. It may beappreciated that in embodiments in which the deployment device offersdual deployment as described herein, two or more selector buttons may beincluded. However, in cases where the deployment device includes asingle deployment system, only one selector button, or no selectorbutton, may be included.

Referring now to FIG. 13A, for purposes of clarity, an isolatedperspective view of the body 920 with the housing removed is presented.Body 920 includes provisions to actuate components of the deploymenttube assembly. Body 920 may also include provisions for easily holdingdeployment device 900. To this end, body 920 may include handgriptrigger 922. Handgrip trigger 922 may be designed to accommodate eithera left or right hand. A user's hand may engage handgrip trigger 922 andwrap around a portion of housing 926 in order to squeeze the handgriptrigger 922 upward and actuate the device. It may be appreciated that insome embodiments, a variety of different materials, coatings and/orsurface treatments can be used handgrip trigger 620 and housing 926 toimprove grip and prevent slipping.

In different embodiments, the handgrip trigger 922 may be coupled toadditional actuating components that reside within body 920, and whichenable the actuation of a pushing member in the deployment device. Forexample, the handgrip trigger 922 may, when actuated, cause a change ina linkage assembly 1320 from a first configuration to a secondconfiguration (see FIGS. 17A-26 below). As shown in FIG. 13A, linkageassembly 1320 comprises a plurality of linking components for permittingthe extending and contracting of the assembly, as will be discussed ingreater detail below. The linkage assembly 1320 can pivot and initiatean actuation sequence in conjunction with an actuation assembly 1300. Indifferent embodiments, the actuation assembly 1300 can include a sliderassembly 1310, a compression spring (“spring”) 1330, and a set of anchorengaging rod drivers (“drivers”) 1340. The spring 1330 surrounds aspring-engaging post or protruding portion 1332, which has an elongatedgeometry and extends from both sides of the slider assembly 1310. Withinan interior space formed in the slider assembly 1310, the drivers 1340are connected to a set of pushing members (a first pushing member 1302and a second pushing member 1304) that extend from the tube housing 914into the body 920 (see FIGS. 14A-15 ). Pushing members may also bereferred to herein as needle blocks.

In order to provide the reader with a greater understanding of thecomponents housed in body 920, an exploded perspective view of the body920 is illustrated in FIG. 13B. In FIG. 13B, the housing 926 can be seento comprise first housing side 1242 and second housing side 1244. Thehandgrip trigger 922 includes a substantially hollow interior space 1322designed to receive and movably connect with a lower portion of a firstlink 1320 a of linkage assembly 1320. In some embodiments, the trigger922 further includes a set of pivoting or rocker elements (shown here astwo knobs extending outward from exterior surface of the trigger 922),operation of which will be discussed further below. In addition, asnoted above, in some embodiments, trigger 922 may include grippingelements 1326 that can improve a user's grip on the device.

With reference to the linkage assembly 1320, first link 1320 a ismovably connected to a second link 1320 b, and second link 1320 b ismovably connected to a third link 1320 c, which is movably connected toslider assembly 1310, seen here to comprise a first sliding component1310 a and a second sliding component 1310 b. For purposes of reference,the second sliding component 1310 b is shown as comprising severalregions, including a first region 1370, a second region 1380, a thirdregion 1390, and a fourth region 1392. The first region 1370 and secondregion 1380 together comprise a forward region 1376 of the slidingcomponent. In addition, first region 1370 of the sliding componentincludes tongue portions or ridges 1308 that extend medially inward. Theridges 1308 in each sliding component are sized and dimensioned toengage with a plurality of grooves formed along the sides of the pushingmembers (see FIG. 17B and 17C). The fourth region 1392 includes portionsthat are configured to engaged with the linkage assembly 1320. Whileonly the second sliding component 1310 b includes the above labels, itshould be understood that these regions are also present in firstsliding component 1310 a. In one embodiment, each sliding component iscomplementary or a mirror-image with respect to the opposing slidingcomponent, except for the location of the ridges in first region 1370.More specifically, the ridges in the first sliding component 1310 a aredisposed near or abut an uppermost edge of the first region, and theridges in the second sliding component 1310 a are disposed near or abuta lowermost edge of the first region.

In different embodiments, the third link 1310 c is configured to pivotaround and relative to the protruding portion 1332 that extends from themedial-facing sides of the fourth region 1392 of each sliding component.Surrounding the first region 1370 is selector assembly 1324, whichcomprises two selector buttons and a substantially rectangular openinginto which slider assembly 1310 extends. Depression of a selector buttonon either side can push against the adjacent sliding component in amedial direction, in turn engaging the corresponding pushing member (seeFIG. 20 ). The set of drivers 1340, including a first driver 1340 a anda second driver 1340 b, are arranged symmetrically or mirror-imagesrelative to one another and are disposed between first sliding component1310 a and second sliding component 1310 b. The first driver 1340 afurther includes a first driver spring 1342 a and the second driver 1340b includes a second driver spring 1342 b.

Referring now to FIG. 14A, for purposes of context, an isolatedperspective view of the tube assembly 910 is shown. The tube assembly910 includes a tip portion 930 with primary opening 1230 at its distalend from which the anchor is released. The tip portion 930 is joined tothe elongated tube housing 914 in which multiple components and portionsthereof are disposed. Extending outward from a rear or proximal openingare a pair of pushing members 1420 (comprising the first pushing memberand second pushing member). Disposed within a channel formed along afirst side of the upper pushing member is a first anchor engaging rod1480, and disposed within a channel formed along a first side of thelower pushing member is a second anchor engaging rod 1490. In someembodiments, each channel includes a slit opening from which the anchorengaging rods can be seen. In one embodiment, the interior components ofthe tube housing 914 are arranged substantially symmetrically relativeto a central longitudinal axis 1450.

Turning to FIG. 14B, the tube assembly 910 is depicted without theexterior tube housing 914, revealing the interior deployment components.The pushing members 1420 can be seen to extend from a region adjacent toand behind tip portion 930 until entering the housing 926 of body 920through an aperture 1472 formed on the distal end of the housing 926. Arear portion 1436 of the pushing members 1420 then extends proximallyinto housing 926 and contacts with components of actuation assembly1300. For example, in FIG. 14B, engaging portions 1434 of the pushingmembers 1420 are partially disposed between the two sliding componentscomprising the slider assembly 1310. Also visible are the two anchorengaging rods 1482 extending along the sides of the pushing members 1420that are configured to engage with drivers 1342 (see FIG. 13B). In someembodiments, the anchor engaging rods 1482 are further movably securedor retained within the channels formed in pushing members 1420 byretaining clips 1414.

In order to better illustrate the distinct components of tube assembly910, an exploded perspective view of the tube assembly 910 isillustrated in FIG. 15 . As noted above, tube assembly 910 includesprovisions to deploy one or more anchors from the tube assembly 910. Inthis example, an exterior of tube assembly 910 includes tube housing 914and tip portion 912, and provides a continuous interior compartmentextending from primary opening 1230 and continuing into a secondaryopening 1530 formed in a distal end of tube housing 914. In someembodiments, the compartment is substantially cylindrical in shape. Insome embodiments, the tube housing 914 also includes window openings1510 that provide a view of the interior configuration or state of thepushing members. For example, a first window may be present on an uppersurface of the tube housing 914, and a second window may be present on alower surface of the tube housing 914. In some cases, the two windowscan be aligned with one another relative to the transverse axis 380.

In the example of FIG. 15 , interior components of tube assembly 910includes first pushing member 1302 and second pushing member 1304, thefirst anchor engaging rod 1480, the second anchor engaging rod 1490, afirst retaining clip 1514, a second retaining clip 1524, a first needlemember 1512 a, a second needle member 1512 b, a third needle member 1522a, and a fourth needle member 1522 b. When the deployment device hasbeen loaded, the tube assembly 910 also includes one or both of firstanchor 1210 and second anchor 1220.

In different embodiments, the first pushing member 1302 and secondpushing member 1304 can be substantially similar in shape anddimensions, though oriented in opposing directions. Thus, whenassembled, a substantially flat underside of first pushing member 1302faces directly toward and in some cases can be in contact with asubstantially flat upper surface of second pushing member 1304. Forpurposes of reference, the first pushing member 1302 is shown ascomprising several portions, including a forward portion 1530 (furtherincluding a nose portion 1528), an intermediate portion 1518, a recessedportion 1532, and an engaging portion 1534. While only the first pushingmember 1302 includes such labels in FIG. 15 , it should be understoodthat these portions are also present in second pushing member 1304 aswell.

In some embodiments, when deployment device is in its initial or neutralconfiguration (prior to actuation), both forward portion 1530 andintermediate portion 1518 are disposed within the tube housing 914.However, when deployment device is in the actuated configuration, thenose portion 1528 can move forward from tube housing 914 into the tipportion 912 in order to push the anchor and needle members in a distaldirection out of primary opening (e.g., see FIG. 30 ). In addition,while recessed portion 1532 and engaging portion 1534 are discussedherein as comprising components of the tube assembly 910, they are eachconfigured to extend into the body housing and/or engage with componentsdisposed in the body of the deployment device. The engaging portion ofeach pushing member further includes a plurality of grooves 1562 formedbetween the spaces between a pair of ledges 1560, and an end portion1564 (shown here with reference to second pushing member 1304). Furtherdetails regarding engaging portion 1534 will be discussed below in FIGS.17A-C.

In some embodiments, the first anchor engaging rod 1480 and the secondanchor engaging rod 1490 can be substantially similar in shape anddimensions, though oriented in opposing directions. In this example,each anchor engaging rod includes an elongated U-shape comprising threeportions. Thus, first anchor engaging rod 1480 includes a first prong orarm 1582 that is substantially parallel to and aligned with a secondprong or arm 1586. The first prong 1582 and second prong 1586 arebridged together by a first hook portion 1584. Similarly, second anchorengaging rod 1490 includes a third prong or arm 1592 that issubstantially parallel to and aligned with a fourth prong or arm 1596.The third prong 1592 and fourth prong 1596 are bridged together by asecond hook portion 1594.

Central longitudinal axis 1410 was first represented in FIG. 14A. It isalso included in FIG. 15 , and should be understood to extend through acenterline of the tube assembly 910. Thus, the medial direction (i.e.,toward the center) from any component of tube assembly 910 should beunderstood to be a direction that extends toward the centrallongitudinal line 1410. It may be appreciated that while the majority ofthe prong portions of each anchor engaging rod are substantially linearand parallel to the central longitudinal axis 1410, the hook portionsare U-shaped. Thus, each anchor engaging rod comprises a continuous,elongated U-shaped rod. Furthermore, each hook portion is orienteddiagonally relative to the central longitudinal axis 1410. In otherwords, each hook portion is slightly bent in a direction away fromcentral longitudinal axis 1410. Thus, first hook portion 1584 is aU-shaped segment that bends or curves upward, and second hook portion1594 is a U-shaped segment that bends or curves downward. The functionsof the hook portions will be discussed with reference to FIGS. 18-25below.

As noted earlier, each pushing member also includes channels forreceiving portions of each anchor engaging rod. In FIG. 15 , firstpushing member 1302 can be seen to include a first channel 1516 thatextends along the first side 1030 of a lower edge of the intermediateportion 1518 and recessed portion 1532. Although not shown here, itshould be understood that a second channel is similarly formed on thesecond side 1130 of the intermediate portion 1518 and recessed portion1532. In addition, second pushing member 1304 includes a third channel1526 and a fourth channel that is formed on the opposite side. Eachchannel is shaped and sized to snugly accommodate the prongs of eachanchor engaging rod, providing a secure hold of the prong while alsoallowing smooth movement back and forth along the channel. In someembodiments, the channel has a longitudinal opening with a transversewidth that is smaller than the diameter of the prong disposed within thechannel in order to prevent the prong from escaping from the channel.Similarly, the recessed portion 1532 of each pushing member isconfigured to slide back and forth between the body of the deploymentdevice and the tube housing 914 via the aperture formed in the bodyhousing. Thus, the recessed portion 1532 has a smaller transversethickness and a substantially flat upper surface, allowing it to movesmoothly through the body housing.

In some embodiments, the tube assembly 910 includes provisions forreleasing each anchor from the deployment device. As shown in FIG. 15 ,the tube assembly 910 further includes needle members for holdinganchors and to provide a space in which anchor engaging rods caninteract with loaded anchors. More specifically, a first beam of firstanchor 1210 is housed in or movably retained by an elongated chamberformed in first needle member 1512 a and a second beam of first anchor1210 is housed in or movably retained by an elongated chamber formed insecond needle member 1512 b. Similarly, a first beam of second anchor1220 is movably retained in or held by an elongated chamber formed inthird needle member 1522 a and a second beam of second anchor 1220 ismovably retained in or held by an elongated chamber fourth formed infourth needle member 1522 b.

Furthermore, the barbs and connecting member of each anchor (see FIG. 3) extend outward from each needle member through an elongated slitformed along a medial side of each needle member, allowing the anchor tobe disposed in both needle members simultaneously. To this end, the twoneedle members are spaced apart a first distance 1582 that correspondsto the lateral width of the connecting member. Thus, in someembodiments, the barbs and connecting member of each anchor are exposedwithin the tube assembly 910 relative to the first beam and second beamwhich are retained in the chambers of needle members. It can beunderstood that each chamber is shaped and sized to snugly accommodatethe beams of each anchor, providing a secure hold of the beam while alsoallowing smooth movement of the anchor back and forth along the chamber.In other words, each elongated slit has a transverse width that issmaller than the diameter of the beam and larger than the diameter ofthe connecting member and transverse width of the barbs in order tosecurely retain the anchor in the two needle members, and allowretraction of the needle members until the anchors are released suchthat deployment occurs.

In order to ensure each needle member maintains its position relative tothe pushing member when the pushing member translates back and forthwithin the deployment device, in some embodiments, the pushing memberand needle member may be secured or otherwise fastened together. Forexample, in FIG. 15 , first needle member 1512 a and second needlemember 1512 b are held or joined to forward portion 1530 of the firstpushing member 1302 by first retaining clip 1514. Similarly, thirdneedle member 1522 a and fourth needle member 1522 b are held or joinedto the forward portion of the second pushing member 1304 by secondretaining clip 1524. The curved retaining clip is secured within arecessed region provided in the forward portion 1530 sized anddimensioned to snugly receive the retaining clip, and the retaining clip‘hugs’ the proximal ends of the needle member such that the needlemember is held flush and securely in place against a substantiallyconcave sidewall region of the forward portion.

Additional details regarding the distal end of the tube assembly 910 arenow provided with reference to FIG. 16 , which depicts a partialexploded perspective view of components of the tube assembly 910. Forpurposes of clarity, the four needle members have been isolated in FIG.16 , and the anchors and anchor engaging rods have been removed from theneedle members. As noted above, in some embodiments, each of the needlemembers may be understood to be substantially similar components. Thus,it can be observed that first needle member 1512 a includes a forwardopening 1616 and a rear opening 1620, and similarly second needle member1512 b includes a forward opening 1610 and a rear opening 1620. Inaddition, third needle member 1522 a includes a forward opening 1636 anda rear opening 1640, and similarly fourth needle member 1522 b includesa forward opening 1630 and a rear opening 1634. Furthermore, secondneedle member 1512 b can be seen to include a first slit 1612 extendingacross the longitudinal length of the tube and fourth needle member 1522b includes a second slit 1632 extending across the longitudinal lengthof the needle member. It should be understood that first needle member1512 a and third needle member 1512 b also includes such slits, allowingfor the free movement of the anchor through the needle members from theforward opening to the rear opening.

The isolated view of first anchor 1210 and first anchor engaging rod1480 and the similar view of second anchor 1220 and second anchorengaging rod 1490 also offer more clarity regarding the pushingfunctionality of the deployment device. As shown in FIG. 16 , a seconddistance 1644 between the first prong 1582 and the second prong 1586 issubstantially equal to a third distance 1642 between the first beam andthe second beam of first anchor 1210, allowing the two components to bealigned in a longitudinal plane. In addition, a first disc 1652 of firstanchor 1210 has a surface area and shape that is substantially similarto that of a first distal end 1656 of the first prong 1582. Similarly, asecond disc 1654 of first anchor 1220 has a surface area and shape thatis substantially similar to that of a second distal end 1658 of thesecond prong 1586. Each distal end may also be referred to as a pushingportion or pushing surface herein. As depicted by dotted lines, the twosurfaces face one another and are configured to press against oneanother when actuation occurs. Thus, when the anchor engaging rod movesforward, the adjacent anchor is pushed at the same time in the samedirection.

The exemplary configuration of actuating components shown in FIGS. 9-16provide a way to convert the upward translation of the trigger into acorresponding distal translation of the pushing members. This allows theforce generated by squeezing the trigger to be converted into a forcethat drives an anchor through a graft and underlying tissue. As anexample, FIGS. 17A-26 together show how an anchor is made to be deployedfrom tip portion 912 when the handgrip trigger 922 is squeezed. In FIG.17A, deployment device 900 is shown in a primary locked configuration1750, with first pushing member 1302 and second pushing member 1304retracted or stowed. The primary locked configuration 1750 refers to thestate in which the deployment device has not been actuated, but adepression of a selector button has occurred. The neutral position, notshown here, refers to the state in which the deployment device has notbeen actuated, nor has a selector button been depressed. The spring 1330is also in its initial extended configuration around the protrudingportion 1332. Furthermore, the linkage assembly 1320 is in an initialcontracted position. In this first stage, for purposes of example, thesecond selector button 1124 is depressed, as shown in FIGS. 11 and 12earlier. In other cases, the first selector button may be depressedfirst.

In some embodiments, depression of second selector button 1124 causes achange in the relative position of the second sliding component 1310 bin the body 920. This arrangement is now discussed with reference toFIGS. 17B and 17C. When no selector buttons are depressed, both slidingcomponents remain spaced apart from the pushing members. However, once aselector button is depressed, the corresponding sliding component shiftsposition in order to engage with the adjacent pushing member's engagingportion. FIGS. 17B and 17C provide two perspective cutaway views of theselector assembly 1324. In FIGS. 17A and 17B, engaging portions 1534 ofthe first pushing member 1302 and second pushing member 1304, as well asthe forward region 1376 of each of the first sliding component 1310 aand second sliding component 1310 b, are presented. The second selectorbutton 1124 has been depressed.

In FIG. 17B, it can be seen that as a result of the depression of secondselector button 1124, the second sliding component 1310 b has beencompressed or pushed inward, such that the two ridges (shown here as afirst ridge 1776 and a second ridge 1778) are now inserted into orreceived by the engaging portion of the first pushing member 1302. Morespecifically, first ridge 1776 has been inserted into a first groove1772 and second ridge 1778 has been inserted into a second groove 1774.In different embodiments, the shape and size of each groove isconfigured to snugly receive each corresponding ridge. Thus, in oneembodiment, each ridge lies flush against or directly adjacent to thethree inner surfaces comprising each groove. By filling the two groovespaces, the ridges and ledges form a substantially continuous uppersurface along the second side 1032 of the engaging portion of the firstpushing member 1302. Furthermore, a first rear ridge 1788 is now pressedagainst the outer side of the end portion of the first pushing member1302. Thus, the first pushing member 1302 is now ‘locked’ to the secondsliding component 1310 b, such that it will hold its relative positionwith the second sliding component 1310 b if the second sliding component1310 b moves forward or rearward.

In contrast, along the first side 1030 of the device, the first selectorbutton 924 remains in the un-pressed, neutral, or initial state. Asshown in FIG. 17B, when a selector button has not been depressed, theadjacent sliding component remains spaced apart from the engagingportion of the pushing members. In other words, in this case, a thirdridge 1766 is disposed outside of a third groove 1762 formed along thefirst side 1030 of second pushing member 1302, and a fourth ridge 1768is disposed outside of a fourth groove 1764 formed along the first side1030 of the second pushing member 1304. Similarly, a second rear ridge1786 is also spaced apart from the end portion of the second pushingmember 1304. Thus, the second pushing member 1304 is ‘unlocked’ withrespect to the first sliding component 1310 a, such that it will nothold its relative position with the first sliding component 1310 a ifthe first sliding component 1310 a moves forward or rearward. It shouldbe understood that when neither selector button has been depressed, bothsides of the deployment device are in this arrangement, also referred toas the neutral configuration.

As noted earlier with respect to FIG. 13 , each sliding component can becomplementary or a mirror-image with respect to the opposing slidingcomponent, except for the location of the ridges in the first region1370. More specifically, the third ridge 1766, fourth ridge 1768, andsecond rear ridge 1786 are disposed along the lower half of the firstregion of the first sliding component 1302, and are therefore alignedwith the grooves formed in the lowermost second pushing member 1304.Similarly, the first ridge 1776 and second ridge 1778 and first rearridge 1788 are disposed along the upper half of the first region of thesecond sliding component 1304, and are therefore aligned with thegrooves formed in the uppermost first pushing member 1302.

For purposes of clarity regarding the functionality of the selectorbuttons, FIG. 17C presents the assembly of FIG. 17B with the secondsliding component 1310 b removed from the assembly. The mechanism bywhich the second pushing member 1304 is locked into position is nowvisible, as well as the stacking arrangement of the first pushing member1302 over the second pushing member 1304. As shown in FIG. 17C,depression of second selector button 1124 also causes a change in therelative position of the second selector button 1124 in the body 920.When no selector buttons are depressed, both selector buttons remainspaced apart from the pushing members. However, once a selector buttonis depressed, a set of locking projections shifts position in a mediallyinward direction in order to engage with the adjacent pushing member'sengaging portion.

In FIG. 17C, it can be seen that as a result of the depression of secondselector button 1124, the second selector button 1124 has beencompressed or pushed inward, such that the two locking projections(shown here as a first projection 1786 and a second projection 1788) arenow inserted into or received by the engaging portion of the secondpushing member 1304. More specifically, first projection 1786 has beeninserted into a fifth groove 1782 and second projection 1788 has beeninserted into a sixth groove 1784. In different embodiments, the shapeand size of each groove is configured to snugly receive eachcorresponding projection. Thus, in one embodiment, each projection liesflush against or directly adjacent to the three inner surfacescomprising each groove. By filling the two groove spaces, theprojections and ledges form a substantially continuous upper surfacealong the second side 1032 of the engaging portion of the second pushingmember 1304. The second pushing member 1304 is now ‘locked’ to thesecond selector button 1124, such that it will hold its relativeposition with the second selector button 1124 while other neighboringcomponents move forward or rearward. In other words, the first set ofgrooves formed on the second side 1032 of the first pushing member 1302have been filled by the ridges of the second sliding component 1310 b,and the second set of grooves on the second side 1032 of the secondpushing member 1304 have been filled by the projections of the secondselector button 1124. Furthermore, the second set of grooves can beunderstood to be aligned with and disposed directly below the first setof grooves while deployment device is in the primary lockedconfiguration 1750.

FIG. 18 presents a cutaway side view of a portion of the deploymentdevice in the primary locked configuration 1750 in which the housing andfirst sliding component have been removed to reveal the relativearrangement of the pushing members, anchor engaging rods, and drivers.In FIG. 18 , it can be observed that the system is substantiallysymmetrical with respect to the central longitudinal axis. Thus, thefirst pushing member 1302 is disposed directly above and aligned withthe second pushing member 1304, the first anchor engaging rod 1480 isdisposed directly above and aligned with the second anchor engaging rod1490, and the first driver 1340 a is disposed directly above and alignedwith the second driver 1340 b. In addition, the two anchor engaging rodscan be seen to extend through an opening or space formed between theL-shaped end portion 1564 of the two pushing members. The hook portionsof each anchor engaging rod are disposed behind driver head portions1860, such that each hook portion surrounds or wraps around a lateralwidth of the adjacent driver. In some embodiments, the proximal end ofthe hook portion, curving away from the central longitudinal axis, is incontact with and/or presses against a corner 1850 formed in the L-shapedend portion of each pushing member. Furthermore, the recessed portion1532 of both pushing members can be understood to be disposed primarilywithin the body housing (not shown).

FIG. 19 presents a cutaway perspective view of a portion of thedeployment device in the primary locked configuration 1750 in which thetube housing, tip portion, and two needle members have been removed toreveal the relative arrangement of the pushing members, anchor engagingrods, and anchors. In FIG. 19 , it can be observed that the system issubstantially symmetrical with respect to the central longitudinal axis.Thus, the nose portions of the first pushing member 1302 and secondpushing member 1304 are aligned with one another, the first anchorengaging rod 1480 is disposed directly above and aligned with the secondanchor engaging rod 1490, the second needle member 1512 b is disposeddirectly above and aligned with the fourth needle member 1522 b, and thefirst anchor 1210 is disposed directly above and aligned with the secondanchor 1220. The removal of the first needle member and third needlemember also more clearly illustrates the relationship between the lowerends (discs) of the anchors with the distal ends of the anchor engagingrods, whereby the anchor engaging rods are in direct contact with eachanchor.

Referring now to FIGS. 20-23 , deployment device 900 is shown in aprimary actuated configuration 2050, with first pushing member 1302 slidforward and second pushing member 1304 retaining its original position.The spring 1330 is now in its compressed configuration around theprotruding portion 1332. Furthermore, the linkage assembly 1320 hastransitioned from its contracted position to an extended position. Inthis second stage, the second selector button 1124 continues to bedepressed, as described in FIGS. 17A-19 above.

In some embodiments, the trigger 922 is configured to pivot in either afirst rotary direction or an opposing second rotary direction via a pairof cylindrical rocker elements that extend outward from the trigger 922and are movably or rotatably secured in small tubes formed in thehousing. Thus, depression of the proximal end of the trigger 922 causesrotation of the trigger 922 such that the proximal end moves upward inthe first rotary direction while the distal end moves downward. In otherwords, the distal end of the trigger 922 is at a lowermost position, andthe proximal end of the trigger 922 is at an uppermost position.

In the perspective of FIG. 20 , as trigger 922 is compressed, it can beseen that the trigger 922 pivots in a generally counter-clockwisedirection. Furthermore, trigger 922 is biased to return to its neutralposition, by way of spring 1330 which extends around the protrudingportion 1332. The motion of the trigger 922 as it moves upward istranslated into further rotational motion by the pivoting portions ofthe linkage assembly 1320, causing the linkage assembly 1320 tostraighten and lengthen in the longitudinal direction. This same motioncauses the slider assembly 1310 to be pushed forward, resulting in acompression of the spring 1330 around protruding portion 1332 as itmeets and presses against a distal surface 2032 of the fourth region1392 of slider assembly 1310.

As discussed with respect to FIGS. 17B and 17C, the engaging portion ofthe first pushing member 1302 is locked to the sliding component 1310 bin this example (due to the depression of the second selector button).Thus, when slider assembly 1310 is pushed distally forward from aninitial or first position to an actuated or second position, firstpushing member 1302 is also carried or pushed forward the same distanceinto the actuated position. In contrast, second pushing member 1304,being locked to the second selector button, retains its original, stowedposition. Furthermore, the recessed portion of the first pushing memberis now disposed primarily within the tube housing (not shown), while therecessed portion of the second pushing member is disposed primarilywithin the body housing (not shown).

The new relative positioning of the first pushing member 1302 to thesecond pushing member 1304 is more clearly observable in the cutawayside view of the deployment device in FIG. 21 . In this view, thehousing and first sliding component have again been removed to revealthe relative arrangement of the pushing members, anchor engaging rods,and drivers. In FIG. 21 , it can be observed that the system, in thisconfiguration, is no longer substantially symmetrical with respect tothe central longitudinal axis. Thus, the first pushing member 1302 isnow disposed more distally relative to the second pushing member 1304 bya fourth distance 2100, and the first anchor engaging rod 1480 isdisposed more distally relative to the second anchor engaging rod 1490by a fifth distance 2102. In one embodiment, fifth distance 2102 issubstantially similar to the fourth distance 2100. However, it isimportant to note that both the first driver 1340 a and second driver1340 b retain their positions during this stage and remain alignedrelative to one another, even as the slider assembly 1310 has translatedforward. However, the relative position of the slider assembly 1310 tothe two drivers has changed such that both drivers are now disposednearer to the fourth region 1392 of the slider assembly 1310 than in thefirst stage.

In addition, while the hook portion of the second anchor engaging rod1490 is still disposed behind the driver head portions 1860, the firstanchor engaging rod 1480 has moved forward such that it no longerextends around the head portion of either driver. Rather, the firstanchor engaging rod 1480 is now completely distal relative to the firstdriver 1340 a, having been pushed forward by the distal surface of thecorner 1850 of the L-shaped end portion of the first pushing member1302.

FIGS. 22 and 23 present cutaway perspective views of a portion of thedeployment device in the primary actuated configuration 2050 in whichthe tube housing, tip portion, and two needle members have again beenremoved to reveal the relative arrangement of the pushing members,anchor engaging rods, and anchors. FIG. 22 depicts an upper perspectiveview and FIG. 23 depicts a lower perspective view. In FIGS. 22 and 23 itcan be observed that the system is no longer symmetrical with respect tothe central longitudinal axis. Thus, the nose portion of the firstpushing member 1302 is distal relative to the nose portion of the secondpushing member 1304. In concert with this move forward, the first anchorengaging rod 1480 and second needle member 1512 b, held alongside thefirst pushing member 1302 by the first retaining clip 1514 (included inthis drawing for purposes of clarity), also project outward furtherrelative to the second anchor engaging rod 1490. The movement forward ofthe first anchor engaging rod 1480 has caused a pushing force to beapplied to the first anchor 1210, such that first anchor 1210 nowextends further outward by a sixth distance 2200 relative to the secondanchor 1220. In one embodiment, fourth distance 2100 and fifth distance2102 (see FIG. 21 ) are substantially similar to the sixth distance 2200shown in FIG. 22 .

In use, the deployment device may be used in one of two ways. In somecases, the tip of the deployment device may be held against theimplant/graft/tissue and the trigger pulled in order to deploy theneedle members and pierce the implant/graft/tissue. In other cases, theneedle members may be deployed first, before engaging theimplant/graft/tissue, and then the deployment device may be advanced asa whole in order to sink the needle members into theimplant/graft/tissue. Referring next to FIGS. 24-26 , deployment device900 is shown in an initial deployed configuration 2450, with firstpushing member 1302 having slid backward until again aligning withsecond pushing member 1304. The spring 1330 has returned to an extendedconfiguration around the protruding portion 1332. Furthermore, thelinkage assembly 1320 has transitioned back from the extended positionto its contracted (neutral) position. In this third stage, the secondselector button 1124 continues to be depressed, as described in FIGS.17A-19 above.

In different embodiments, in order for the transition from the primaryactuated configuration 2050 (shown in FIGS. 20-23 ) to the initialdeployed configuration 2450 to occur, the handgrip trigger 922 is rockedin the second rotary direction. In the perspective of FIG. 24 , thetrigger 922 would be pivoted in a generally clockwise direction. Thus,depression of the distal end of the trigger 922 causes rotation of thetrigger 922 such that the distal end moves upward in the second rotarydirection while the proximal end moves downward. In this case, once thedeployment device operator has positioned the tip portion at the desiredlocation, he or she can rock the trigger 922 in the opposite directionto release the first anchor 1210. Furthermore, once handgrip trigger 922is released, the spring 1330 biases the trigger 922 to return to theneutral position, which is reflected in the depiction of FIG. 24 .

Thus, rocking the trigger 922 in the second rotary direction causes thelinkage assembly 1320 to contract, which further causes the sliderassembly 1310 to be pulled back in a rearward or proximal direction. Asdiscussed with respect to FIGS. 17B and 17C, the engaging portion of thefirst pushing member 1302 is locked to the sliding component 1310 b.When slider assembly 1310 is pulled proximally rearward, first pushingmember 1302 is also carried or moved backward the same distance. Incontrast, second pushing member 1304, being locked to the secondselector button, continues to retain its original position. Thus, thetranslational movement of the slider assembly 1310 in a proximaldirection pulls the locked first pushing member 1302 until first pushingmember 1302 is again aligned with second pushing member 1304. The swiftretraction of the first pushing member 1302 retracts the needle members,thus releasing the first anchor 1210 from the deployment device 900, asshown in FIG. 24 .

The new relative positioning of the first pushing member 1302 to thesecond pushing member 1304 is more clearly observable in the cutawayside view of the deployment device in FIG. 25 . In this view, thehousing and first sliding component are removed to reveal the relativearrangement of the pushing members, anchor engaging rods, and drivers.In FIG. 25 , it can be observed that several components of the systemare once again substantially symmetrical with respect to the centrallongitudinal axis. Thus, the first pushing member 1302 is disposeddirectly above and aligned with the second pushing member 1304, and thefirst driver 1340 a is disposed directly above and aligned with thesecond driver 1340 b. However, while the first pushing member 1302 movesback in a proximal direction, the first driver 1340 applies a forceagainst the hook portion of first anchor engaging rod 1480, ensuringthat it remains in its actuated position, disposed forward relative tothe second anchor engaging rod 1490 by the fifth distance 2102.

Furthermore, both the first driver 1340 a and second driver 1340 bretain their positions during this stage and remain aligned relative toone another, even as the slider assembly 1310 has translated backward.In this case, the position of the two drivers relative to the sliderassembly 1310 has changed such that both drivers are disposed distallyfurther from the fourth region 1392 of the slider assembly 1310 than inthe second stage.

FIG. 26 presents a cutaway perspective view of a portion of thedeployment device in the initial deployed configuration 2450 in whichthe tube housing, tip portion, and two needle members are removed toreveal the relative arrangement of the pushing members, anchor engagingrods, and anchors. In FIG. 26 it can be observed that while the pushingmembers are symmetrical with respect to the central longitudinal axis,the remaining components are staggered. Thus, the nose portions of thefirst pushing member 1302 and second pushing member 1304 are alignedwith one another, and the second needle member 1512 b has also beenretracted and returned to its original position and thus is disposeddirectly above and aligned with the fourth needle member 1522 b.However, the first anchor engaging rod 1480 remains distal relative tothe second anchor engaging rod 1490 by a seventh distance 2600. In oneembodiment, seventh distance 2600 is substantially equal to sixthdistance 2200 of FIG. 22 . This results in a tip region 2680 of bothprongs of the first anchor engaging rod 1480 to protrude outward fromtheir needle members by a fourth distance 2610, while both prongs of thesecond anchor engaging rod 1490 remain enclosed within their respectiveneedle members. That is, because the first anchor engaging rod 1480remains extended while first needle member 1512 b and the second needlemember (not shown in FIG. 26 ) are retracted, the anchor remains inplace (e.g., inserted into the patient's tissue) while the needlemembers are retracted, thus releasing/deploying the anchor from thedeployment device. That is, because the needle members are withdrawnindependent of the anchor engaging rod, the anchoring device remainsstatic with respect to the tissue and with respect to the body of thedeployment device. Accordingly, the anchoring device remains in place atthe implanted location when the deployment device is withdrawn. Theremoval of the first needle member and third needle member in FIG. 26also more clearly illustrates the absence of the first anchor 1210 fromthe tube assembly, and the remaining loaded second anchor 1220.

Additional context regarding the function of the deployment device isnow provided with reference to FIGS. 27-33 , which will illustrate thedeployment sequence for the second anchor. In FIG. 27 , a forward-facingview of deployment device 900 depicts a secondary locked configuration2750 whereby the first selector button 924 has been depressed and one ofthe two anchors has been previously deployed. Thus, the dual deploymentsystem now has only a single anchor (second anchor 1220). Secondselector button 1124 has returned to its initial or neutral state. Indifferent embodiments, selection of one button can automatically causethe other button to ‘pop’ back out to the neutral position. In someother embodiments, a press of an already depressed button can return thebutton to its neutral state. In another example, deployment canautomatically return the button to its neutral state.

As a general matter, unless otherwise noted, the mechanism for thedeployment of second anchor 1220 is similar to that depicted for thefirst anchor 1210 in FIGS. 17A-26 . In the secondary lockedconfiguration 2750, the second anchor 1220, as well as the othercomponents of tube assembly 910, are all interiorly disposed, as shownin the side-view of FIG. 28 . FIG. 28 offers an exterior view of thedeployment device 900 that includes body housing 926, tube housing 914,and tip portion 912, in order to provide further understanding of theembodiments.

FIG. 29 presents a cutaway perspective view of a portion of thedeployment device in the secondary locked configuration 2750 in whichthe tube housing, tip portion, and two needle members have been removedto reveal the relative arrangement of the pushing members, anchorengaging rods, and anchors. In FIG. 29 , it can be observed that thecomponents shown are arranged as they were in the initial deployedconfiguration 2450 of FIG. 26 .

In the subsequent state of FIGS. 30 and 31 , a secondary actuatedconfiguration 3050 is presented, whereby the first selector button 924is depressed, one of the two anchors has been deployed, and the handgriptrigger 922 has been re-actuated. In FIG. 30 , a side view of theexterior of deployment device 900 is illustrated, revealing that thesecondary actuated configuration 3050 (as well as primary actuatedconfiguration 2050 of FIG. 20 ) is associated with a protrusion of thethird receiving tube 1522 a for second pushing member from the tipportion 912. In this view, a projected portion 3022 comprising thesecond anchor (not shown), third needle member 1522 a, and fourth needlemember (not shown) is exposed and disposed outside of the tube assembly910. It can be understood that the complementary fourth receiving tube1522 b, while not visible in FIG. 30 , also protrudes distally outwardby the same amount.

In FIG. 31 , a cutaway perspective view of a portion of the deploymentdevice in the secondary actuated configuration 3050 is shown in whichthe tube housing, tip portion, and two needle members have been removedto reveal the relative arrangement of the pushing members, anchorengaging rods, and anchors. In FIG. 31 , the second pushing member 1304is now distal relative to the first pushing member 1302. The firstanchor engaging rod 1480 and the second anchor engaging rod 1490 areonce again aligned, while the fourth receiving tube 1512 b has moved inthe distal direction by an eighth distance 3120. In one embodiment,eighth distance 3120 is substantially equal to seventh distance 2600.Although not shown in this figure, it should be understood that thethird needle member moves in concert with the fourth needle member 1512b.

Thus, second pushing member 1304 has translated in the distal directionuntil both prongs of the second anchor engaging rod 1490 have pushed thesecond anchor 1220 outside of tip portion 912. The second anchor 1220,third needle member (not shown), and fourth needle member 1522 b,collectively referred to as projected portion 3022, are outside of thetube housing. It can be appreciated that, while disposed outside of thetube housing, second anchor 1220 remains stowed in the third and fourthneedle members.

Referring to FIGS. 32 and 33 , once the force on trigger 922 isreleased, as discussed earlier, the spring acts to bias the trigger backto the neutral position and also pulls the second pushing member back sothat the needle members are fully retracted within tip portion 912. FIG.33 depicts a cutaway perspective view that shows the distal ends 3310 ofboth anchor engaging rods protruding out from the ends of the receivingtubes by the same amount. Thus, both anchor engaging rods are now in thesame state as the first anchor engaging rod 1480 was during both theinitial deployed configuration 2450 of FIG. 26 and the secondary lockedconfiguration 2750 of FIG. 29 . Furthermore, in contrast to the initialprimary locked configuration of FIG. 19 , the anchor engaging rods arenow the most distal component of the interior components comprising tubeassembly 910.

FIGS. 34 and 35 are schematic, perspective illustrations of needlemembers with an anchoring device disposed therein in a configuration inwhich the two elements are driven into tissue/graft material. FIG. 32illustrates anchoring device 1210 disposed within first needle member1512A and second needle member 1512B. As further shown in FIG. 34 , theconnecting member 3400 of anchoring device 1210 extends between firstneedle member 1512A and second needle member 1512B. Also extending fromthe slots in the needle members are the barbs of anchoring device 1210.As shown in FIG. 34 , a first barb 3405 and a second barb 3410 extendout of the slot in first needle member 1512A and a third barb 3415 and afourth barb 3420 extend out of the slot in second needle member 1512B.

In some embodiments, the needle members may have Greene tip needlegrinds, e.g., with an outer bevel and a curved edge. For example, asshown in FIG. 34 , second needle member 1512B includes a distal tip 3425and an outer bevel 3430 on the outward edge. In addition, as furthershown in FIG. 34 , the distal end of second needle member 1512B mayinclude a curved edge 3435. This curved edge 3435 generally correspondsto the scalloped portion 397 of the anchor device shown in FIG. 3 .

In addition, when in the piercing condition, the anchoring device may berecessed from the distal tips of the needle members. For example, asshown in FIG. 35 , the beveled distal surface 3500 of anchoring device1210 is recessed from the distal end of second needle member 1512B by adistance 3505. This prevents the graft/tissue from compressing when thecombination of the needle member and anchoring device pierces thegraft/tissue.

It will be understood that the configuration of the second needle member1512B and anchoring device 1210 shown in FIGS. 34 and 35 and discussedabove may also apply to first needle member 1512A and anchoring device1210. Further, such configurations may also apply to third needle member1522A, fourth needle member 1522B, and anchoring device 1220 shown inFIG. 16 . It will be further understood that, in some embodiments, theconfiguration between one anchoring device and the corresponding needlemembers may be different than the configuration between a secondanchoring device and its, respectively corresponding needle members.

Although the embodiments describe an anchoring system that is used tosecure tissue grafts to other tissue in the body, it may be appreciatedthat this system could also be used with synthetic structures. Forexample, the anchoring system could be used to attach syntheticmaterials to other tissues in a body.

While various embodiments are described, the description is intended tobe exemplary, rather than limiting and it will be apparent to those ofordinary skill in the art that many more embodiments and implementationsare possible that are within the scope of the disclosed embodiments.Although many possible combinations of features are shown in theaccompanying figures and discussed in this detailed description, manyother combinations of the disclosed features are possible. Any featureor element of any embodiment may be used in combination with orsubstituted for any other feature or element in any other embodimentunless specifically restricted. Further, unless otherwise specified, anystep in a method or function of a system may take place in any relativeorder in relation to any other step described herein.

What is claimed is:
 1. A surgical anchoring device, comprising: a firstbeam and a second beam each extending along a longitudinal direction;and a connecting member bridging a first proximal portion of the firstbeam to a second proximal portion of the second beam such that the firstbeam is substantially aligned with the second beam; a first barbprotruding from a medial side of the first beam, wherein the first barbextends diagonally in a generally proximal direction; and a second barbprotruding from a medial side of the second beam, wherein the secondbarb extends diagonally in a generally proximal direction; wherein thefirst barb includes a proximal facing surface that is separated from thefirst beam by a recess.
 2. The anchoring device of claim 1, furtherincluding a reinforcing ridge disposed within the first recess.
 3. Theanchoring device of claim 1, wherein the connecting member extendsfurther proximally than the proximal ends of the beams.
 4. The anchoringdevice of claim 1, wherein the first beam, second beam, connectingmember, first barb, and second barb comprise a monolithic structureformed of a single unitary piece of material.
 5. The anchoring device ofclaim 1, wherein the first beam extends between a proximal end and adistal end, the proximal end terminating in a first surface having afirst shape and the distal end terminating in a second surface having asubstantially different shape.
 6. The anchoring device of claim 5,wherein the proximal end terminates in a substantially circular surfaceand the distal end terminates in a substantially teardrop-shapedsurface.
 7. The anchoring device of claim 6, wherein the proximal endterminates in a surface aligned with a lateral axis and the distal endterminates in a surface oriented at an oblique angle relative to thelateral axis.
 8. The anchoring device of claim 7, wherein the third barbis contiguous with the distal end of the first beam.
 9. A deploymentdevice for deploying a surgical anchoring device, the deployment devicecomprising: at least one pair of needle members configured to beextended from a distal end of the deployment device and configured toreceive beams of a surgical anchoring device; at least one anchorengaging rod configured to engage with an anchoring device when disposedwithin the needle members; and at least one pushing member configured totranslate the pair of needles and the anchoring device from a first,proximal position within the deployment device to a second, distalposition extending from the distal end of the deployment device;wherein, upon retraction of the needle members, the anchor engaging rodmaintains the anchoring device in the second, distal position such thatthe anchoring device is released from the needle members.
 10. Thedeployment device according to claim 9, wherein the anchor engaging rodis substantially U-shaped, having two distal ends that engage with theanchoring device within the needle members.
 11. The deployment deviceaccording to claim 10, wherein anchor engaging rod is movably retainedwithin a pair of channels formed along both sides of the pushing member.12. The deployment device according to claim 9, further including asecond pushing member, a second pair of needle members, and a secondanchor engaging rod, such that the deployment device is configured to beloaded with and deploy more than one anchoring device.
 13. Thedeployment device of claim 9, further comprising a body housing anactuating assembly, wherein the actuating assembly is configured to:push the first anchor engaging rod from a first position to a secondposition when a first button is depressed on the body and the deploymentdevice is actuated, and push the second anchor engaging rod from a thirdposition to a fourth position when a second button is depressed on thebody and the deployment device is actuated.
 14. A method of implanting asurgical anchoring device, comprising: providing a deployment deviceloaded with a first anchoring device comprising a frame structureincluding a first beam and a second beam bridged together by aconnecting member and having a retention portion proximate a distal endof the first anchoring device configured to resist withdrawal of theanchoring device from tissue; the deployment device comprising: at leastone pair of needle members, including a first needle member and a secondneedle member configured to receive the first beam and the second beamof the first anchoring device; at least one anchor engaging rodconfigured to engage with the first anchoring device when disposedwithin the needle members; and at least one pushing member configured toengage the pair of needles and the anchor engaging rod; the methodfurther comprising: actuating the at least one pushing member, therebytranslating the pair of needles and the first anchoring device from afirst position within the deployment device to a second positionextending from the distal end of the deployment device; and retractingthe needle members independent of the anchor engaging rod such that theanchor engaging rod maintains the anchoring device in the secondposition, thereby releasing the anchoring device from the needlemembers.
 15. The method of claim 14, wherein the first beam and thesecond beam of the first anchoring device each include a plurality ofbarbs that extend medially from the first beam and the second beam. 16.The method of claim 14, wherein actuating the pushing member isperformed using a handgrip trigger.
 17. The method of claim 16, whereinthe handgrip trigger includes a rocker mechanism wherein rocking thehandgrip trigger in a first direction extends the needle members and theanchor engaging rod.
 18. The method of claim 17, wherein rocking thehandgrip trigger in a second direction withdraws the needle membersindependent of the anchor engaging rod.
 19. The method of claim 14,further comprising: using the deployment device to implant a secondanchoring device using a substantially duplicate deployment assembly.20. The method of claim 19, wherein the deployment device includes aselector mechanism, wherein method further includes using the selectormechanism to choose which of multiple anchoring devices loaded into thedeployment device is deployed.